FDA Related News

Federal Register

FDA, Critical Path Institute Workshop on Patient-reported Outcomes

Federal Register notice: FDA and the Critical Path Institutes Patient-Reported Outcome Consortium announce a 4/25 public workshop entitled Second Annu...

Federal Register

Comments Sought on Device Exceptions for Informed Consent

Federal Register notice: FDA requests comments on an information collection for its interim final rule Medical Devices; Exception From General Require...

FDA General

5 Challenges for FDA Commissioner-nominee Scott Gottlieb

Two professors discuss five challenges facing FDA commissioner-nominee Scott Gottlieb.

Human Drugs

NE Compounding Center Owner Fights Fraud Claim

A part owner of the defunct New England Compounding Center says he cant be guilty of fraud against FDA because there was no legal bright line differen...

Campaign Needed to Boost Trial Enrollment: Coalition

The Coalition for Clinical Trial Awareness asks Congress to include in PDUFA a three-step process to raise awareness of the value of clinical trials a...

Human Drugs

FDA Denies Metabolic Therapy OTC Petition

FDA denies a Metabolic Therapy petition to amend an OTC monograph to indicate that melatonin and IP6 are safe and effective for analgesic drug product...

Human Drugs

FDA Denies Petition to Amend Inform Consent Documents

FDA denies a Center for Responsible Science petition asking for three specific warnings in informed consent documents.

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes one citing Targeted Medical Pharma.

Topics Suggested for Combination Products Policy Council

Three stakeholders suggest topics for the FDA Combination Products Policy Council to address.

Medical Devices

FDA Class 1 Recall on Medtronic Field Action

FDA classifies as a Class 1 recall a Medtronic voluntary field action related to its HVAD System Controllers and DC Adapters.